BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6646267 · Received June 16, 2017

    Report

    Report Number
    2025587-2017-00980
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    August 18, 2015
    Report Date
    June 2, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: M. ABDEL-WAHAB ET AL. "1-YEAR OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH BALLOON-EXPANDABLE VERSUS SELF-EXPANDABLE VALVES RESULTS FROM THE CHOICE RANDOMIZED CLINICAL TRIAL" J AM COLL CARDIOL 2015;66:791¿800. HTTP://DX.DOI.ORG/10.1016/J.JACC.2015.06.026 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE . NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING 1-YEAR OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH BALLOON-EXPANDABLE VERSUS SELF-EXPANDABLE VALVES. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED 241 PATIENTS, PREDOMINATELY FEMALE, MEAN AGE 82 YEARS), OF WHICH 120 WERE IMPLANTED WITH A MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). OVERALL DURING THE STUDY, FIFTEEN DEATHS (ELEVEN WERE CARDIOVASCULAR) WERE REPORTED IN THE SELF-EXPANDABLE VALVE GROUP, HOWEVER BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO A MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STROKE, MI, HEART FAILURE, BLEEDING, ENDOCARDITIS, VALVE DYSFUNCTION, ATRIAL FIBRILLATION, PACEMAKER IMPLANT, BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427899 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R